Propulsive drug delivery from a swallowable device into a patient's intestinal tract

Abstract

Embodiments of the invention provide swallowable devices, preparations, and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs or other therapeutic agents (TA) into a wall of the GI tract such as the stomach or small intestine. The swallowable device comprises a sensor, a combustible propellant (CP) and a therapeutic agent preparation (TAP) comprising at least one TA. The sensor triggers the CP to ignite and propel the TAP into the wall of the GI tract in response to an external condition or change in external condition. Embodiments of the invention are particularly useful for orally delivering drugs or other TAs which are degraded within the GI tract and require parenteral injection.

1 - 36 . (canceled) 
     
     
         37 . A swallowable device for delivering a therapeutic agent preparation to a patient, the device comprising:
 a swallowable capsule having a capsule wall;   a therapeutic agent preparation held inside the capsule;   a propulsive driver within the capsule configured to advance the therapeutic agent preparation through the capsule wall and into a wall of the gastrointestinal (GI) tract, or into and through the wall into the peritoneal wall and/or peritoneal cavity of the patient, wherein the propulsive driver comprises a combustible propellant and an igniter; and   wherein the igniter is configured to ignite the combustible propellant in response to a condition in the GI tract external to the capsule.   
     
     
         38 . The device of  claim 37 , wherein the igniter is configured to ignite the combustible propellant in response to an external condition in the GI tract selected from moisture, temperature, pH, pressure, and proximity of the device to a wall of the GI tract. 
     
     
         39 . The device of  claim 37 , further comprising a sensor in the capsule wall and coupled to the igniter, wherein the sensor senses the value of the external condition and causes the igniter to ignite the combustible propellant when a threshold value of the external condition is reached. 
     
     
         40 . The device of  claim 39 , wherein the sensor is electronic and produces an electrical signal representative of the sensed condition. 
     
     
         41 . The device of  claim 40 , wherein the igniter comprises a trigger circuit that receives the signal representative of the sensed condition from the sensor and that generates an ignition current and delivers the ignition current to the combustible propellant. 
     
     
         42 . The device of  claim 41 , wherein the trigger circuit includes a battery and a capacitor, wherein the battery charges the capacitor and the capacitor discharges the current into the propellant. 
     
     
         43 . The device of  claim 42 , wherein the trigger circuit further includes wire filaments in the propellant, wherein the wire filaments produce heat sufficient to ignite the propellant as the current is discharged from the capacitor therethrough. 
     
     
         44 . The device of  claim 43 , wherein the propellant comprises nitrocellulose. 
     
     
         45 . The device of  claim 37 , wherein the propulsive driver comprises a piston and a cylinder, wherein the combustible propellant is at a bottom of the cylinder beneath the piston and the therapeutic agent preparation is on an upper surface of the piston. 
     
     
         46 . The device of  claim 45 , wherein the propellant comprises a layer of nitrocellulose formed along the bottom of the cylinder. 
     
     
         47 . The device of  claim 46 , wherein the layer comprises from 0.1 gm to 0.5 gm of nitrocellulose. 
     
     
         48 . The device of  claim 37 , wherein the therapeutic agent preparation is in a solid form and comprises an active agent compressed with at least one of an excipient or a binder into an elongate member having a tapered, sharpened, or honed tip. 
     
     
         49 . The device of  claim 37 , wherein the swallowable capsule wall comprises a cylindrical shell. 
     
     
         50 . The device of  claim 37 , wherein at least a portion of the capsule wall is degradable in the patient's GI tract. 
     
     
         51 . The device of  claim 50 , wherein the at least a portion of the capsule wall degrades at a pH equal to or greater than about 6.5. 
     
     
         52 . The device of  claim 37 , wherein the therapeutic agent preparation is in a solid form and comprises a first solid dosage therapeutic agent preparation and a second solid dosage therapeutic agent preparation; the device further comprising:
 a second propulsive driver configured to drive the second solid dosage therapeutic agent preparation in a direction different from the first solid dosage therapeutic agent preparation.   
     
     
         53 . The device of  claim 52 , wherein the first propulsive driver and second propulsive driver are configured to drive the first solid dosage therapeutic agent preparation and second solid dosage therapeutic agent preparation in at least two diametrically opposed directions. 
     
     
         54 . The device of  claim 37 , wherein the sensor comprises a mechanical or fluidic sensor element on an external region of the swallowable capsule that changes state in response to a change in the external condition. 
     
     
         55 . The device of  claim 54 , wherein the igniter comprises a mechanical or fluidic igniter element that responds to a change of state of the mechanical or fluidic sensor and mechanically generates energy to ignite the combustible propellant. 
     
     
         56 . The device of  claim 37 , wherein the therapeutic agent preparation is in a liquid or a semi-liquid form.